NCT04175613

A Long-term Extension Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis

A Phase 3b, Multi Center, Open-label, Long-term Extension Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

This study was created to provide subjects who complete Week 52 (end of Apremilast Extension Phase) of study CC-10004-PPSO-003 the option to continue to receive open-label apremilast therapy. The study will consist of up to 208 weeks of long-term treatment followed by an 8-week observational follow-up phase.

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	Apremilast	Apremilast dose will be increased from 20 mg BID to 30 mg BID for those subjects that reach a weight of 50 kg or more during the study

Timeline

• Start date: 2019-12-20
• Primary completion: 2025-10-30
• Completion: 2025-12-12
• First posted: 2019-11-25
• Last updated: 2025-12-22

Locations

50 sites across 9 countries: United States, Belgium, Canada, Czechia, France, Israel, Italy, Russia, Spain

Regulatory

• FDA-regulated drug study